Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2007-003392-39 | |||
| Spanish AEM: ALM-ALM-2008-01 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a observational, open, prospective, single arm cohort study within authorized SPC conditions to describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Primary Objective:
To describe the effectiveness of Almotriptan in treating acute migraine attacks when pain is mild and in the first hour of pain in everyday primary care clinical practice.
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Pain Free | 2 h from intake |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Pain Free | 24 h | |
| SNAE (Sustained pain free and No Adverse Events) | 24 h | |
| Relapse |
Not provided
Inclusion Criteria:
8.Female patients of childbearing potential must not suspect to be pregnant and have an effective method of birth control for at least 30 days prior to study entry and throughout the study.
11.After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
12.Patients must either use Almotriptan for their migraine acute attacks treatment or prove through the ANAES scale in the basal visit that a change in their treatment approach is required.
Exclusion Criteria:
11.Patients taking any of the prohibited concomitant medications listed in Section 10.3.1 of the protocol.
12.Patients who have used any of the following medications within 7 days of study entry and during the trial: sustained release opioids and/or semi-synthetic or long acting opioids.
16.Women who are pregnant or lactating.
18.Patients who have received an investigational drug or used an investigational device within 30 days of study entry.
Not provided
Not provided
Following SPC conditions and study requirements, male or female of 18 to 65 years old with a minimum of one year of migraine history (International Headache Society criteria, see criteria attached in the protocol Annex 1) of moderate or severe intensity and with a frequency of 2 to 6 attacks per month for the past 3 months.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michel Lanteri-Minet, Dr | Pain Evaluation and Treatment Department, Hopital Pasteur, Nice, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 28 GPs across France | Diverse | France | ||||
| 26 GPs across Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20584227 | Derived | Lanteri-Minet M, Diaz-Insa S, Leone M, Vila C, Clissold SP; START Study. Efficacy of almotriptan in early intervention for treatment of acute migraine in a primary care setting: the START study. Int J Clin Pract. 2010 Jun;64(7):936-43. doi: 10.1111/j.1742-1241.2010.02379.x. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 24 h |
| Second tablet / rescue medication use | 24 h |
| Associated symptoms presence evolution: Nausea, Vomiting, Photophobia, Phonophobia. | Basal - 2h - 24h |
| Migraine attack duration | 24 h |
| Time loss (functional disability) | 24 h |
| Patients' satisfaction: | Basal - After each attack |
| Adverse Events | From recruitment to study end or AE resolution |
| Consistency of response to treatment between attacks (2 h PF in 2/3 attacks) | 2 months |
| Diverse |
| Italy |
| 26 GP practices across Spain | Diverse | Spain |
| D009422 | Nervous System Diseases |